Multiple SclerosisNCT07037966
Advancing Portable Brain Imaging: The NextMRI Project's Role in Revolutionizing Diagnostic MRI
A study testing MRI in people with Multiple Sclerosis, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
Mobile imaging diagnostic devices are extremely valuable for clinical diagnosis both inside and outside healthcare facilities. However, Magnetic Resonance Imaging (MRI)-the gold standard for diagnosing many neurological and musculoskeletal conditions-is not easily portable. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 7 Nov 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected multiple sclerosis or or undergoing clinical review/follow-up for MS
Who cannot join
- Any contradictions for high-field MRI
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario y Politécnico la Fe
Valencia, Valencia, 46026
About this study
Official title: Truly Portable MRI for Extremity and Brain Imaging Anywhere & Everywhere
Mobile imaging diagnostic devices are extremely valuable for clinical diagnosis both inside and outside healthcare facilities. However, Magnetic Resonance Imaging (MRI)-the gold standard for diagnosing many neurological and musculoskeletal conditions-is not easily portable. Moreover, due to its high cost (in the million-euro range) and limited availability, the average wait time in Europe for an MRI scan is from several weeks to months.
The NextMRI project aims to take the technical, industrial, and commercial steps required to deploy portable low-field MRI systems in remote and developing regions, rural areas, sporting events, military or medical camps, and home healthcare settings, improving diagnostic capabilities. The specific goals of the NextMRI project are:
- Expand current low-field MRI technology to brain imaging.
- Enhance diagnostic accuracy using machine learning.
- Improve portability and usability for end users.
- Reduce production costs for broader affordability.
- Collect clinical evidence through trials to validate medical performance.
- Develop a sustainable business model for market commercialization.
Read the detailed description
Based on this context, the NextMRI project will carry out a clinical evaluation study involving a multidisciplinary team of radiologists, rheumatologists, physiotherapists, data managers, and physicists. The study will focus on patients with suspected multiple sclerosis (MS). Its main goals are to:
- Assess the diagnostic value of the low-field MRI prototype.
- Evaluate usability for end users.
- Train AI algorithms using deep learning to differentiate between healthy and damaged tissues, thereby aiding radiologists, reducing diagnostic time, and lightening their workload.
Radiologists will first generate structured reports based on standard high-resolution MRI scans. They will then evaluate the low-field MRI images from the NextMRI prototype. The initial high-field MRI reports will serve as the reference standard for assessing performance and training the AI system.
Each patient will undergo two MRI scans on the same day (after providing informed consent): one at the standard 3T MR scan and other at the low-field MRI scan (NextMRI). To prevent bias, both scans will be interpreted by a professional radiologist with an 8-week interval between readings.
A total of 50 patients aged between 18 and 65 years with suspected multiple sclerosis will be included. Patients with any contraindications for high-field MRI will be excluded from the study.
- Conditions
- Multiple Sclerosis
- Being tested
- MRI
- Keywords
- multiple sclerosis, MRI, Brain Imaging
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Standard 3T MRI Scan
MRIDevice
Low-field MRI scan using the NextMRI prototype
| Study group | Role | What they receive |
|---|---|---|
| Patients with Suspected Multiple Sclerosis | Experimental | A total of 50 patients aged between 18 and 65 years with suspected multiple sclerosis will be scanned using both the 3T MRI and the NextMRI prototype. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological reports to Evaluate NextMRI prototype performance
A clinical evaluation study will be performed involving a multidisciplinary team of radiologists, traumatologists, rheumatologists, physiotherapists, data managers and physicists.
The validation strategy will be structured in 3 steps:
- Radiologists will report the high-resolution MR images in a structured report as part of their clinical duties.
- Radiologists will evaluate the MR images acquired with the PR Gen III scanner after 8 weeks, in order be blind to the first reading and avoid learning interobserver bias
- Finally, the gold standard information obtained by the initial radiological report will serve to evaluate the prototype performance and train the Deep Learning tools.
The report documents technical details, contrast use, and lesion analysis in brain, spine, and medulla. It quantifies key MS-related lesions, categorizes locations, and notes other abnormalities. A diagnostic impression summarizes findings to support MS diagnosis.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Patient Comfort and Satisfaction Questionnaire to Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner
Patients provide insights into their experiences with both scanners, focusing on aspects such as ease of entry and exit, comfort during positioning, perception of claustrophobia, noise levels, and overall satisfaction. Additionally, they compare the two scanners directly, offering valuable perspectives on which device they prefer and why. Their comments highlight subjective comfort and practical challenges, which are critical for improving patient-centered design.
The Questionnaire will use a Likert scale (e.g., from 1 = very uncomfortable to 5 = very comfortable) combined with open-ended questions for additional comments.
Measured: 1 year
User Comfort and Satisfaction Questionnaire Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner
Healthcare professionals, including radiologists and MRI technicians, evaluate the scanners from an operational standpoint. Their feedback covers ease of use, image quality, workflow efficiency, technical issues, and overall satisfaction with the device's performance. They also compare the NextMRI prototype to the standard scanner, assessing its potential impact on clinical practice, particularly for patients with conditions like Multiple Sclerosis. Professionals are asked to identify any anticipated challenges in implementation and to suggest additional training or resources needed for optimal use.
The Questionnaire will use a Likert scale (e.g., from 1 = very uncomfortable to 5 = very comfortable) combined with open-ended questions for additional comments.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start7 Nov 2025
- Primary completion12 Jun 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention. There's no randomization.-the aim is to evaluate the performance of the device within the same group of patients.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037966
- Sponsor's protocol ID
- NextMRI Brain Validation
- Status last verified
- Sep 2026
- First submitted
- 20 May 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guallart-Naval T, Algarin JM, Pellicer-Guridi R, Galve F, Vives-Gilabert Y, Bosch R, Pallas E, Gonzalez JM, Rigla JP, Martinez P, Lloris FJ, Borreguero J, Marcos-Perucho A, Negnevitsky V, Marti-Bonmati L, Rios A, Benlloch JM, Alonso J. Portable magnetic resonance imaging of patients indoors, outdoors and at home. Sci Rep. 2022 Jul 30;12(1):13147. doi: 10.1038/s41598-022-17472-w.
PubMed 35907975O'Reilly T, Teeuwisse WM, de Gans D, Koolstra K, Webb AG. In vivo 3D brain and extremity MRI at 50 mT using a permanent magnet Halbach array. Magn Reson Med. 2021 Jan;85(1):495-505. doi: 10.1002/mrm.28396. Epub 2020 Jul 5.
PubMed 32627235
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Truly Portable MRI for Extremity and Brain Imaging Anywhere & Everywhere
- ClinicalTrials.gov ID
- NCT07037966
- Acronym / sponsor ID
- NextMRI Brain Validation
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, MRI, Brain Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- National Research Council, Spain
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mobile imaging diagnostic devices are extremely valuable for clinical diagnosis both inside and outside healthcare facilities. However, Magnetic Resonance Imaging (MRI)-the gold standard for diagnosing many neurological and musculoskeletal conditions-is not easily portable. Moreover, due to its high cost (in the million-euro range) and limited availability, the average wait time in Europe for an MRI scan is from several weeks to months.
The NextMRI project aims to take the technical, industrial, and commercial steps required to deploy portable low-field MRI systems in remote and developing regions, rural areas, sporting events, military or medical camps, and home healthcare settings, improving diagnostic capabilities. The specific goals of the NextMRI project are:
- Expand current low-field MRI technology to brain imaging.
- Enhance diagnostic accuracy using machine learning.
- Improve portability and usability for end users.
- Reduce production costs for broader affordability.
- Collect clinical evidence through trials to validate medical performance.
- Develop a sustainable business model for market commercialization.
Detailed description
Based on this context, the NextMRI project will carry out a clinical evaluation study involving a multidisciplinary team of radiologists, rheumatologists, physiotherapists, data managers, and physicists. The study will focus on patients with suspected multiple sclerosis (MS). Its main goals are to:
- Assess the diagnostic value of the low-field MRI prototype.
- Evaluate usability for end users.
- Train AI algorithms using deep learning to differentiate between healthy and damaged tissues, thereby aiding radiologists, reducing diagnostic time, and lightening their workload.
Radiologists will first generate structured reports based on standard high-resolution MRI scans. They will then evaluate the low-field MRI images from the NextMRI prototype. The initial high-field MRI reports will serve as the reference standard for assessing performance and training the AI system.
Each patient will undergo two MRI scans on the same day (after providing informed consent): one at the standard 3T MR scan and other at the low-field MRI scan (NextMRI). To prevent bias, both scans will be interpreted by a professional radiologist with an 8-week interval between readings.
A total of 50 patients aged between 18 and 65 years with suspected multiple sclerosis will be included. Patients with any contraindications for high-field MRI will be excluded from the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same intervention. There's no randomization.-the aim is to evaluate the performance of the device within the same group of patients.
| Arm | Type | Receives |
|---|---|---|
| Patients with Suspected Multiple Sclerosis | Experimental | Device: MRIA total of 50 patients aged between 18 and 65 years with suspected multiple sclerosis will be scanned using both the 3T MRI and the NextMRI prototype. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with suspected multiple sclerosis or or undergoing clinical review/follow-up for MS
Key exclusion criteria (1 listed)
- Any contradictions for high-field MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIStandard 3T MRI Scan | Device | Patients with Suspected Multiple Sclerosis |
| MRILow-field MRI scan using the NextMRI prototype | Device | Patients with Suspected Multiple Sclerosis |
Primary outcome
Radiological reports to Evaluate NextMRI prototype performance
Time frame: Through study completion, an average of 1 year
A clinical evaluation study will be performed involving a multidisciplinary team of radiologists, traumatologists, rheumatologists, physiotherapists, data managers and physicists. The validation strategy will be structured in 3 steps: 1. Radiologists will report the high-resolution MR images in a structured report as part of their clinical duties. 2. Radiologists will evaluate the MR images acquired with the PR Gen III scanner after 8 weeks, in order be blind to the first reading and avoid learning interobserver bias 3. Finally, the gold standard information obtained by the initial radiological report will serve to evaluate the prototype performance and train the Deep Learning tools. The report documents technical details, contrast use, and lesion analysis in brain, spine, and medulla. It quantifies key MS-related lesions, categorizes locations, and notes other abnormalities. A diagnostic impression summarizes findings to support MS diagnosis.
2 secondary outcomes
Patient Comfort and Satisfaction Questionnaire to Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner
Time frame: 1 year
User Comfort and Satisfaction Questionnaire Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 35907975Guallart-Naval T, Algarin JM, Pellicer-Guridi R, Galve F, Vives-Gilabert Y, Bosch R, Pallas E, Gonzalez JM, Rigla JP, Martinez P, Lloris FJ, Borreguero J, Marcos-Perucho A, Negnevitsky V, Marti-Bonmati L, Rios A, Benlloch JM, Alonso J. Portable magnetic resonance imaging of patients indoors, outdoors and at home. Sci Rep. 2022 Jul 30;12(1):13147. doi: 10.1038/s41598-022-17472-w.
- Background: PubMed 32627235O'Reilly T, Teeuwisse WM, de Gans D, Koolstra K, Webb AG. In vivo 3D brain and extremity MRI at 50 mT using a permanent magnet Halbach array. Magn Reson Med. 2021 Jan;85(1):495-505. doi: 10.1002/mrm.28396. Epub 2020 Jul 5.
- Truly portable MRI for extremity and brain imaging anywhere \& everywhereLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Multiple Sclerosis, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological reports to Evaluate NextMRI prototype performance (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07037966, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.